Medial and Lateral Combined Ligament Arthroscopic Repair for Multidirectional Ankle Instability: Case Series

Ankle Injuries Clinical Trial

Official title:

Medial and Lateral Combined Ligament Arthroscopic Repair for Multidirectional Ankle Instability: Case Series

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04459910
• Other study ID #: Multi_EPM
• Status: Completed
• Start date: July 1, 2019
• Est. completion date: January 1, 2021

Study information

• Verified date: February 2021
• Source: Federal University of São Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Abstract Introduction: The high prevalence of sprains in the population has provided a substantial number of patients with lateral instability of the ankle. The continuity of this condition can lead to the progressive loosening of the medial containment structures, generating a multidirectional rotational instability. The deltoid approach through the imbrication of its components has been proposed as a solution for these patients. The arthroscopic technique has been described as an alternative. Methods: This is a retrospective study with patients diagnosed with multidirectional instability and submitted to an ankle arthroscopy with medial repair (arthroscopic tensioning) and lateral (arthroscopic Brostrom) between January 2018 and January 2020. All patients will fill an epidemiological questionnaire and will be evaluated for pain and function according to the Visual Analogue Scale (VAS) and the American Orthopaedic Foot and Ankle Society Score (AOFAS) at 12 months (6-24 months) average of follow-up. Discussion: The combined medial and lateral arthroscopic repair may be an effective and safe alternative in the treatment of multidirectional instability. The inclusion of the deltoid complex and the low invasiveness of this technique can improve the clinical outcomes of these patients. Additional studies, with a prospective and comparative methodology are required to sustain this proposal. Design: Level IV. Retrospective case series. Keywords: ankle injuries; lateral ligament; collateral ligaments; joint instability

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: January 1, 2021
• Est. primary completion date: September 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 65 Years

Eligibility

Inclusion Criteria:

• complaints about ankle loosening for the last six months
• clinical findings of lateral and medial instability

Exclusion Criteria:

• existence of previous surgery
• autoimmune diseases
• neuropathy
• inflammatory disease
• isolated medial instability
• flatfoot
• previous ankle infiltration
• radiographic findings of ankle arthritis
• cavovarus deformity
• coagulopathies
• body mass index over 35
• associated injuries, such as osteochondral lesions
• syndesmosis instability
• tendon ruptures
• fractures

Related Conditions & MeSH terms

• Ankle Injuries
• Deltoid Ligament; Sprain (Strain) (Ankle)
• Joint Instability
• Ligament Injury
• Sprains and Strains
• Talofibular Ligament Tear
• Wounds and Injuries

Intervention

Procedure:
• Arthroscopic Brostrom combined with Arthroscopic Deltoid Repair
After anesthesia and surgical site preparation, traditional arthroscopic portals were performed. A 4.5mm set was used to clean the joint and assess possible associated injuries. Anterolateral and anteromedial impacts were resected when needed. Lateral and medial instability were confirmed arthroscopically, and ligament repairs prepared, starting by the lateral compartment. A traditional Arthroscopic Brostrom was performed, using one anchor and suture passers. Sutures are passed but not tightened. Medial anchor insertion is executed at the medial malleolus, in the quadrant described by Vega et al. Sutures were passed respecting the safe zone illustrated by Acevedo at al. The ankle was positioned in neutral (no posterior drawer) and the lateral sutures tightened with arthroscopic knots. Finally, the medial repair is finalized by tightening the deltoid sutures with the ankle at the same position. Portals were closed and a dressing applied.

Locations

Country	Name	City	State
Brazil	Federal University of Sao Paulo	Sao Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	American Orthopedic Foot and Ankle Society - Hindfoot Score (AOFAS)	Functional Score (0 to 100 | 100 best score possible | 0 worst score possible)	6th post-operataive month
Secondary	Visual Analogue Scale (VAS)	Pain Score (0 to 10 | 10 worst score possible | 0 best score possible)	6th post-operataive month
Secondary	Complications	Surgical complications	6th post-operataive month